• FDA tentatively approves Lupin’s ANDA for generic of Yupelri revefenacin inhalation solution

  According to Lupin, the FDA has tentatively approved the company’s ANDA for revefenacin inhalation solution, a generic of Mylan’s Yupelri inhalation solution. Yupelri was approved by the FDA for the treatment of COPD in 2018.… [Read more . . .]

• Quince Therapeutics to acquire Orphai Therapeutics and its LAM-001 rapamycin DPI

  Quince Therapeutics announced that it has agreed to acquire Orphai Therapeutics (formerly AI Therapeutics, formerly LAM Therapeutics) and its LAM-001 inhaled dry powder rapamycin (sirolimus) for $115 million up front and up to an additional… [Read more . . .]

• SNBL announces new effort to get Satsuma’s Atzumi DHE nasal powder for migraine into the US market

  More than a year after the FDA approved Satsuma’s Atzumi (STS 101) intranasal dry powder dihydroergotamine for the treatment of migraine in adults, Satsuma parent company SNBL says that it is still trying to find… [Read more . . .]

• Vertex ceases development of VX-522 inhaled RNA therapy for CF after stopping Phase 1/2 trial due to tolerability issues

  Vertex has stopped a Phase 1/2 study of VX-522 inhaled RNA therapy for the treatment of cystic fibrosis and has ceased development of the product, the company said in its most recent report of financial… [Read more . . .]

• Enterprise Therapeutics says Phase 2 trial of ETD001 inhaled ENaC blocker for CF met its primary endpoint

  Enterprise Therapeutics announced that a Phase 2 trial of ETD001, an inhaled epithelial sodium channel blocker, met its primary endpoint, demonstrating a statistically significant and clinically relevant improvement in lung function versus placebo after 28… [Read more . . .]

• Chance Pharma reports NMPA acceptance of NDA for CXG87 budesonide / formoterol DPI, Phase 3 results

• Hovione and IDC announce new single-use capsule-based intranasal delivery device for dry powder formulations

• Intertek announces expansion of GMP stability storage facility

• RDD 2026 exhibitor preview

• MannKind is developing ralinepag DPI (MNKD-1501) for United Therapeutics

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